Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365567
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-02-12
Brief Title:
Dietary Fructose a Metabolic Switch in Pediatric Obesity-related Disease
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
Evaluation of Liver and Osteo-metabolic Complications Related to the Consumption of Fructose in a Cohort of Overweight and Obese Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EO2022
Brief Summary:
The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns commercial factors and social determinants it has long-term consequences for both individual health and society as a whole Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet due to the increased availability of ultra-processed and more appealing foods children and adolescents are shifting towards a Western diet One in four children consumes sugary and carbonated drinks every day which contributes to a high intake of fructose in the diet while fruits and vegetables are consumed less and legumes are included in the diet of only 38 of children less than once a week
Fructose is a monosaccharide naturally found in fruits vegetables and honey due to its high sweetness and taste-enhancing properties fructose is widely used in the food industry High-fructose corn syrup in particular is one of the most widely used ingredients in the production of soft drinks jams breakfast cereals and bakery products Non-alcoholic fatty liver disease NAFLD now also called metabolic dysfunction-associated fatty liver disease MAFLD is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis and indirectly through increased uric acid production High-fructose foods also appear to be a risk factor for bone loss Numerous studies conducted over the past 25 years during which fructose consumption has exponentially increased have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density BMD and new bone tissue deposition
The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age and its effective relationship with the onset of liver and osteoarticular complications in this population Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children
Fructose is a monosaccharide naturally found in fruits vegetables and honey due to its high sweetness and taste-enhancing properties fructose is widely used in the food industry High-fructose corn syrup in particular is one of the most widely used ingredients in the production of soft drinks jams breakfast cereals and bakery products Non-alcoholic fatty liver disease NAFLD now also called metabolic dysfunction-associated fatty liver disease MAFLD is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis and indirectly through increased uric acid production High-fructose foods also appear to be a risk factor for bone loss Numerous studies conducted over the past 25 years during which fructose consumption has exponentially increased have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density BMD and new bone tissue deposition
The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age and its effective relationship with the onset of liver and osteoarticular complications in this population Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children
Detailed Description:
At the time of recruitment patients referred to the Endocrinology Outpatient Clinic of the AOU Azienda Ospedaliera Universitaria Maggiore della Carità in Novara the Transition Endocrinology Outpatient Clinic of the Endocrinology SCDU Struttura Complessa a Direzione Universitaria and the Pediatric Endocrinology Outpatient Clinic B Trambusti of the Giovanni XXIII Pediatric Hospital will undergo
Questionnaires to assess the quantity of fructose intake through diet
KIDMED quality index for children and adolescents questionnaire to evaluate adherence to the Mediterranean diet in childrenadolescents
IDEFICS Identification and preven- tion of Dietary- and lifestyle- induced health EFfects In Children and infantS questionnaire to assess food frequency in children
24-hour recall questionnaire to gather information about meals consumed in the previous 24 hours Macronutrient quantities will be obtained using dedicated software Professional Diet Therapy Software Dietosystem from DSMedicaindustry supplying the software The questionnaire includes specific questions and figures to identify food portions and relate them to the quantity of fructose consumed
Calculation of the Dietary Inflammatory Index DII through a list of foods This parameter allows for the determination of how much a dietary pattern promotes the synthesis of pro-inflammatory molecules
Sociological questionnaire prepared ad hoc by Unit 3 to assess dietary habits and fructose intake in relation to the familys socioeconomic status
Anamnestic evaluation
The mother of the patient will be asked for gestational age mode of delivery and the childs birth anthropometric data
Recording of current pharmacological therapy if present
Instrumental evaluation
Quantitative and qualitative analysis of bone composition using quantitative ultrasound QUS This tool provides various parameters related to bone composition specifically speed of sound SOS for bone density evaluation broadband ultrasound attenuation BUA for trabecular structure evaluation ultrasound peak amplitude for trabecular size evaluation number of peaks for connectivity evaluation of the mineralized matrix structure and energy and amplitude of fast waves for elasticity evaluation
Abdominal ultrasound US to assess hepatic steatosis perivisceral and subcutaneous fat The presence of hepatic steatosis NAFLD will be classified from stage 1 to stage 3 according to the literature
Clinical-auxological evaluation
Anthropometric measurements including weight height and BMI according to STANDARD DEVIATION SCORE SDS
Waist and hip circumference measurements
Measurement of blood pressure and heart rate
Analysis of body composition through bioimpedance analysis BIA
Expected results With this study the investigators expect to acquire new knowledge about the effect of fructose on the onset of obesity-associated liver disease NAFLD and bone metabolism by identifying new biological immunological and omics markers that can be studied in the future as disease targets in the pediatric population Furthermore due to scientific and sociological interest this study aims to identify sociodemographic and cultural determinants related to fructose intake which will be useful for creating preventive campaigns aimed at promoting a healthy lifestyle This includes changing dietary habits to encourage a healthy diet and reducing obesity in the population
Questionnaires to assess the quantity of fructose intake through diet
KIDMED quality index for children and adolescents questionnaire to evaluate adherence to the Mediterranean diet in childrenadolescents
IDEFICS Identification and preven- tion of Dietary- and lifestyle- induced health EFfects In Children and infantS questionnaire to assess food frequency in children
24-hour recall questionnaire to gather information about meals consumed in the previous 24 hours Macronutrient quantities will be obtained using dedicated software Professional Diet Therapy Software Dietosystem from DSMedicaindustry supplying the software The questionnaire includes specific questions and figures to identify food portions and relate them to the quantity of fructose consumed
Calculation of the Dietary Inflammatory Index DII through a list of foods This parameter allows for the determination of how much a dietary pattern promotes the synthesis of pro-inflammatory molecules
Sociological questionnaire prepared ad hoc by Unit 3 to assess dietary habits and fructose intake in relation to the familys socioeconomic status
Anamnestic evaluation
The mother of the patient will be asked for gestational age mode of delivery and the childs birth anthropometric data
Recording of current pharmacological therapy if present
Instrumental evaluation
Quantitative and qualitative analysis of bone composition using quantitative ultrasound QUS This tool provides various parameters related to bone composition specifically speed of sound SOS for bone density evaluation broadband ultrasound attenuation BUA for trabecular structure evaluation ultrasound peak amplitude for trabecular size evaluation number of peaks for connectivity evaluation of the mineralized matrix structure and energy and amplitude of fast waves for elasticity evaluation
Abdominal ultrasound US to assess hepatic steatosis perivisceral and subcutaneous fat The presence of hepatic steatosis NAFLD will be classified from stage 1 to stage 3 according to the literature
Clinical-auxological evaluation
Anthropometric measurements including weight height and BMI according to STANDARD DEVIATION SCORE SDS
Waist and hip circumference measurements
Measurement of blood pressure and heart rate
Analysis of body composition through bioimpedance analysis BIA
Expected results With this study the investigators expect to acquire new knowledge about the effect of fructose on the onset of obesity-associated liver disease NAFLD and bone metabolism by identifying new biological immunological and omics markers that can be studied in the future as disease targets in the pediatric population Furthermore due to scientific and sociological interest this study aims to identify sociodemographic and cultural determinants related to fructose intake which will be useful for creating preventive campaigns aimed at promoting a healthy lifestyle This includes changing dietary habits to encourage a healthy diet and reducing obesity in the population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None